National, Multicentre Post Market Surveillance Study on Anterior Pelvic Prolapse Reconstruction With a Titanium-coated Polypropylene Mesh (TiLOOP® PRO A)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 10
- 主要终点
- Patient's Quality of Life
研究概览
简要总结
The purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life.
详细描述
This multicentre, non-randomized, observational clinical investigation will be performed to obtain usability and postmarket information on the TiLOOP® pelvic floor reconstruction meshes and in particular to obtain the improvement of patients' quality of life.
It is expected that the patient's quality of life is meliorated after implantation of a TiLOOP® PRO A mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 12 months is significantly better than before implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Existence of a cystocele. Women with a symptomatic genital descensus: at least stage II (ICS-classification according POP-Q system). This applies to primary as well as recurrent intervention.
- •Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation.
- •Patient information has been handed out and written consent is at hand.
- •Patient has attained full age (18 years or older).
排除标准
- •Unfinished family planning, pregnancy or breast-feeding mother.
- •Known intolerance to the mesh-implants under investigation.
- •Lack of written patients' informed consent.
- •Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
- •Patients with acute (within the last 12 months) carcinoma in the pelvic area.
- •Patients with history of radiotherapy in the pelvic area.
- •Patients with implanted anterior pelvic floor mesh.
- •Patient is institutionalized by court or official order (MPG §20.3).
- •Participation in another interventional clinical investigation.
研究组 & 干预措施
surgical mesh implantation
Standard method to implant the TiLOOP® PRO A surgical mesh transvaginally. Women with a symptomatic genital descensus: at least stage II (ICS-classification according Pelvic Organ Prolapse Quantification System (POP-Q system)). This applies to primary as well as recurrent intervention.
干预措施: TiLOOP® PRO Plus A (Device)
结局指标
主要结局
Patient's Quality of Life
时间窗: 12 months
By means of a validated questionnaire it will be shown whether the subjective quality of life after 12 months is significantly better than before implantation.
次要结局
- Patient's Quality of Life(6 months)
- Adverse Events (AE)(6 weeks, 6 and 12 months)
- Feasibility Check of Mesh implantation(1 day)
- Number of complications and concomitant procedures(1 day)